Guidi Luisa, Pugliese Daniela, Armuzzi Alessandro
Internal Medicine and Gastroenterology, Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, Rome, Italy.
Clin Exp Gastroenterol. 2011;4:163-72. doi: 10.2147/CEG.S14558. Epub 2011 Jul 15.
Anti-tumor necrosis factor alpha (TNF-α) medications are a class of biologics employed in the treatment of patients with inflammatory bowel disease (IBD). Adalimumab is the first fully human monoclonal immunoglobulin directed against TNF-α, which binds with high affinity and specificity to membrane and soluble TNF. Adalimumab administered subcutaneously has demonstrated efficacy in the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and severe chronic psoriasis. Studies have shown that adalimumab is effective for inducing and maintaining remission of moderate-to-severe active Crohn's disease (CD) patients at an induction dose of 160/80 mg (week 0 and 2) and at a maintenance dose of 40 mg every other week. The efficacy of adalimumab as a second-line therapy has also been documented for patients with loss of response or intolerance to infliximab. Adalimumab is also superior to placebo for inducing and maintaining complete perianal fistula closure. It also seems effective for reducing extraintestinal manifestations. The safety profile is similar to that of other anti-TNF therapy in CD patients, with lower immunogenicity and rate of adverse injection reactions than infliximab. Adalimumab is not approved for the treatment of ulcerative colitis (UC). Recently, however, the results of the first randomized, controlled trial on adalimumab for UC showed that adalimumab at 160/80 mg induction dose was safe and effective for inducing remission and clinical response after 8 weeks in patients with moderately-to-severely active UC failing treatment with corticosteroids and/or immunosuppressants. More data are necessary to clarify the therapeutic role of adalimumab in UC. This review of the literature summarizes available data on the efficacy and safety profile adalimumab in patients with IBD.
抗肿瘤坏死因子α(TNF-α)药物是一类用于治疗炎症性肠病(IBD)患者的生物制剂。阿达木单抗是首个完全人源化的抗TNF-α单克隆免疫球蛋白,它以高亲和力和特异性结合膜结合型和可溶性TNF。皮下注射的阿达木单抗已证明对类风湿关节炎、强直性脊柱炎、银屑病关节炎和重度慢性银屑病有治疗效果。研究表明,阿达木单抗以160/80mg(第0周和第2周)的诱导剂量和每2周40mg的维持剂量,对诱导和维持中度至重度活动性克罗恩病(CD)患者的缓解有效。对于对英夫利昔单抗无反应或不耐受的患者,阿达木单抗作为二线治疗的疗效也已得到证实。阿达木单抗在诱导和维持完全性肛周瘘管闭合方面也优于安慰剂。它似乎对减少肠外表现也有效。在CD患者中,其安全性与其他抗TNF治疗相似,免疫原性低于英夫利昔单抗,注射不良反应发生率也较低。阿达木单抗未被批准用于治疗溃疡性结肠炎(UC)。然而,最近关于阿达木单抗治疗UC的首个随机对照试验结果显示,对于中度至重度活动性UC且经皮质类固醇和/或免疫抑制剂治疗失败的患者,160/80mg诱导剂量的阿达木单抗在8周后诱导缓解和临床反应方面是安全有效的。需要更多数据来阐明阿达木单抗在UC中的治疗作用。本文献综述总结了阿达木单抗在IBD患者中的疗效和安全性的现有数据。